Labelling & Mandatory Information

Labelling and mandatory information according to FDA and EU-regulation

For the US market. we implement the labeling of your dietary supplements in compliance with the FDA CFR 21 Part 101 and DSHEA. 

For the European market, many regulations must be taken into account when labeling foods (food supplements, specialty foods): in particular, the EU Health Claim Regulation, EFSA,   provisions of the Food Information Regulation (LMIV, Regulation (EU) No. 1169/2001) and the new Food Information Regulation or Prepackaging Regulation. They specify which mandatory information must be provided on the packaging of food supplements (e.g., list of ingredients, best-before date, or name of the manufacturer).

Labeling, advertising statements and health claims (nutrition and health claims about food) are also regulated under the Health Claims Regulation (EC) No. 1924/2006. Such claims may only be made if they are approved under the Regulation. For many ingredients, the European Commission has published a positive list for permitted health claims in Regulation (EU) No. 432/2012.

Food supplements must also comply with Directive 2002/46/EEC (additional labeling elements), e.g. for information on the recommended intake (amount to be taken daily).

Mandatory labeling and health claims according to the Health Claims Regulation and Regulation (EU) 1169/2011 are essential for the marketability of your product. In addition, Directive 2002/46/EC and the Food Supplements Regulation (NemV) must be checked with regard to further special requirements.

We are happy to support you with the labeling of your products and their product claims. Just contact us!